{"id":2324,"date":"2017-07-03T07:43:47","date_gmt":"2017-07-03T07:43:47","guid":{"rendered":"https:\/\/lynxee.consulting\/?p=2324\/"},"modified":"2017-07-12T07:44:55","modified_gmt":"2017-07-12T07:44:55","slug":"europe-new-efsa-gd-on-dermal-absorption","status":"publish","type":"post","link":"https:\/\/lynxee.consulting\/en\/europe-new-efsa-gd-on-dermal-absorption\/","title":{"rendered":"EUROPE: New EFSA GD on Dermal absorption"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">EFSA was asked by the European Commission to assess the scienti\ufb01c quality of newly available human <\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\"> studies on dermal absorption and, based on the evaluation of the studies, to revise the EFSA PPR Panel guidance on dermal absorption (<\/span><a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.2903\/j.efsa.2012.2665\/epdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">EFSA PPR Panel, 2012<\/span><\/a><span style=\"font-weight: 400;\">).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The guidance proposed new default values to be used in absence of experimental data. Since the new available data clearly show that dermal absorption is significantly affected by the concentration of active substance in the product and by the type of formulation, the<\/span><b> new default values<\/b><span style=\"font-weight: 400;\"> are categorised by formulation type or concentrated and diluted pesticide formulations. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">A comparison of new and current default values is presented below:<\/span><\/p>\n<p><strong>2017 Guidance Document:<\/strong><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>Formulation type<\/b><\/td>\n<td><b>Concentration status<\/b><\/td>\n<td><b>Default dermal absorption \u00a0value<\/b><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"2\"><span style=\"font-weight: 400;\">Organic solvent-based(a) or other(b)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Concentrate<\/span><\/td>\n<td><b>25%<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Dilution<\/span><\/td>\n<td><b>70%<\/b><\/td>\n<\/tr>\n<tr>\n<td rowspan=\"2\"><span style=\"font-weight: 400;\">Water-based(c) or solid(d)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Concentrate<\/span><\/td>\n<td><b>10%<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Dilution<\/span><\/td>\n<td><b>50%<\/b><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">(a): Formulation types: emulsi\ufb01able concentrate (EC), emulsion, oil in water (EW), suspo-emulsion (SE), dispersible concentrate (DC), oil miscible liquids (OL\/OF), oil-based suspension concentrates (OD), emulsion for seed treatment (ES), microemulsion (ME).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(b): Formulation types: bait concentrate (CB), capsule suspension (CS), gel for direct application (GEL\/GD), bait, ready for use (RB), mixture of capsule suspension and suspension concentrate (ZC), seed coated with a pesticide (PS), experimental solution of active substances in solvent (AI).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(c): Formulation types: soluble concentrate (SL), suspension concentrate (SC), \ufb02owable concentrate for seed treatment (FS), \ufb02owable (FL) (=SC).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(d): Formulation types: wettable powder (WP), water-dispersible granules (WG\/WDG), water-soluble granules (SG), water-soluble powder (SP), powder for dry seed treatment (DS).<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong>2012 Guidance Document:<\/strong><\/p>\n<table>\n<tbody>\n<tr>\n<td><\/td>\n<td><b>Default dermal absorption value<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Concentrate<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(&gt; 5% a.s., 50 g\/kg for solids or 50 g\/L for liquids)<\/span><\/td>\n<td><b>25%<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Dilution<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(\u2264 5% a.s.)<\/span><\/td>\n<td><b>75%<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Active substance with<\/span><\/p>\n<p><span style=\"font-weight: 400;\">log Pow &lt; -1 or &gt; 4 and MW &gt; 500<\/span><\/td>\n<td><b>10%<\/b><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">A <\/span><a href=\"https:\/\/www.efsa.europa.eu\/en\/events\/event\/170927\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">technical meeting with stakeholders<\/span><\/a><span style=\"font-weight: 400;\"> will be held in Parma on 27-28 September 2017 to explain how the document differs from the guidance issued in 2012, answer questions and collect feedback.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>To download: <\/b><\/p>\n<p><a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.2903\/j.efsa.2017.4873\/epdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Guidance on dermal absorption<\/span><\/a><span style=\"font-weight: 400;\"> (EFSA Guidance, 24\/05\/2017)<\/span><\/p>\n<p><a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.2903\/sp.efsa.2017.EN-1250\/epdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Outcome of the public consultation on the draft EFSA Guidance on dermal absorption<\/span><\/a><span style=\"font-weight: 400;\"> (EFSA Technical report, 24\/05\/2017)<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>Lynxee consulting<\/b><span style=\"font-weight: 400;\">\u2019s team is at your disposal to answer your questions.<\/span><\/p>\n<p><b>Contact us!<\/b> <a href=\"https:\/\/lynxee.consulting\/en\/contact\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">https:\/\/lynxee.consulting\/en\/contact\/<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EFSA was asked by the European Commission to assess the scienti\ufb01c quality of newly available human in vitro studies on dermal absorption and, based on the<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":4,"featured_media":2321,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[195],"class_list":["post-2324","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulation","tag-human-health"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EUROPE: New EFSA GD on Dermal absorption - Lynxee consulting<\/title>\n<meta name=\"description\" content=\"EFSA was asked by the European Commission to assess the scienti\ufb01c quality of newly available human in vitro studies on dermal absorption and, based on the\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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